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White Replacement Elastic Bands For Durette

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
White Replacement Elastic Bands For Durette FDA UDI
Generic Name
Epiocular radiation shield, reusable FDA UDI
Device Name
White Spare Elastic Headbands for the Durette External Laser Shield with cordlock (5 units) FDA UDI
Model / Reference
21-537 FDA UDI
Description
White Spare Elastic Headbands for the Durette External Laser Shield with cordlock (5 units) FDA UDI

Identifiers

Primary DI / UDI-DI
20697660002488 FDA UDI
FDA Product Code
IWS FDA UDI
GMDN Term
Epiocular radiation shield, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Epiocular radiation shield, reusable

White Replacement Elastic Bands For Durette by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epiocular radiation shield, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (1)

  • FDA UDI 2c635b05-6a98-48ae-a6db-858a1c1e3a22 34 fields · synced May 31, 2026